Fingertip Pulse Oximeter Clinical Test

This study has been completed.
Information provided by (Responsible Party):
Andon Health Co., Ltd Identifier:
First received: May 23, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted

The purpose of this study is to validate the SpO2 accuracy of pulse oximeter equipment in comparison to "gold-standard" measurements of blood SaO2 by a CO-oximeter


Study Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by Andon Health Co., Ltd:

Enrollment: 10
Study Start Date: November 2011
Study Completion Date: December 2011
Fingertip Pulse Oximeter
SPO2 measurement range: 70%-99%
SaO2 measurement range: 70%-99%


Ages Eligible for Study:   25 Years to 32 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

healthy volunteers who consent to induced hypoxia and arterial blood sampling as part of the experimental procedure


Inclusion Criteria:

  • Subjects participate in the study on a voluntary basis
  • All subjects should be in good health at the time of the study. Unless specified otherwise in the protocol, the following values could be applied: COHb<3 %, MetHb<2 %, ctHb>10 g/dl;
  • Inclusion criteria should serve the purpose of the study

Exclusion Criteria:

  • Smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhaemoglobin levels, unless specific dyshaemoglobins are called for in the study protocol.
  • Individuals subject to conditions that result in elevated levels of methaemoglobin, unless specific dyshaemoglobins are called for in the study protocol.
  • Subjects who would be placed at undue medical risk associated with any procedures called for in the protocol (e.g. arterial cannulation or hypoxia).
  • Age: young person and that of more than 50 years old.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Andon Health Co., Ltd Identifier: NCT01605955     History of Changes
Other Study ID Numbers: AndonHealth8
Study First Received: May 23, 2012
Last Updated: May 23, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Andon Health Co., Ltd:
SPO2 processed this record on April 23, 2014